On Site Training: ISO 11607 Packaging Stability and Validation: Ensuring Shelf Life and Package Integrity

This Italian-language classroom training course provides a practical overview of the requirements of ISO 11607-1 and ISO 11607-2, with a focus on Sterile Barrier Systems (SBS), packaging process validation, package integrity, stability studies, and shelf-life determination. Participants will gain practical knowledge on how to demonstrate packaging performance, justify shelf-life claims, and meet current regulatory expectations.

Location and Language

• Location: Eurofins Biolab, Via Bruno Buozzi 2, 20055 Vimodrone (MI), Italy
• Language: Italian

Key Topics

• ISO 11607-1 and ISO 11607-2 requirements
• Sterile Barrier Systems (SBS)
• Packaging process validation
• Stability studies and shelf-life justification
• Package integrity and performance testing
• Regulatory expectations and technical documentation

Who Should Join?

This training is intended for professionals working in Regulatory Affairs, Quality Assurance, R&D, Validation, Packaging, and Manufacturing who are involved in the development, validation, and maintenance of sterile medical device packaging systems.

Speaker

• Rosario Biancuzzo, Medical Devices Consultant Eurofins Consultancy & Regulatory Service
• Leonela Tita Gallo, Medical Devices Consultant Eurofins Consultancy & Regulatory Services

Registration Fees

€750 + VAT

10% discount for registrations completed by 30 July 2026
5% discount for registrations completed by 30 August 2026
10% discount on the second registration from the same company

Click here to register